ID

30859

Description

This ODM file contains Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log and Signature. To be filled if study concluded or withdrawal from study for any reason. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

Versions (1)
  1. 6/27/18 6/27/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 27, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

English

Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0232741
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

To be checked on Session Days 1 pre-dose, 2 hours post-dose and 72 hours post-dose. If Yes, - Stop investigational product and complete date stopped on Investigational Product form. - Contact GSK within 24 hours of occurrence of liver event by phone or fax. - If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. - Obtain tests as per protocol. - Obtain Blood sample for pharmacokinetic (PK) analysis within 24 hours of last dose. - Complete Liver Events Forms.

Data type

text

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C3897431
Was the treatment blind broken during the study?
Description

Treatment Blind Broken

Data type

text

Alias
UMLS CUI [1]
C3897431
If yes, date blind broken
Description

This is the date the Investigator is made aware of the blind being broken. Record either: Date blind was broken by Investigator or Date Investigator notified by GSK that the blind has been/was broken

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If yes, time blind broken
Description

Time blind broken

Data type

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken, pick one
Description

Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Other Reason blind broken, specify
Description

Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form. Not Applicable: not of childbearing potential or male

Data type

text

Alias
UMLS CUI [1]
C3828490
Did a female partner of the male subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form. Not Applicable: subject is female, female partner not of childbearing potential or no female partner)

Data type

text

Alias
UMLS CUI [1,1]
C3828490
UMLS CUI [1,2]
C0919624
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of last contact
Description

Refer to protocol section(s) to evaluate subject completion or withdrawal from the study. If the subject completed the study: ’Date of last contact’ must match the last actual contact with the subject whether or not the contact was a clinic visit. If the subject withdrew from the study: ’Date of decision to withdraw’ must match the date of subject withdrawal. ’Date of last contact’ must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note:An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Description

Withdrawal from study

Data type

text

Alias
UMLS CUI [1]
C0422727
If Yes, pick one primary reason for withdrawal:
Description

If Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. Withdrew consent: Only pick, if none of the other primary reasons are appropriate

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Specify reason for withdrawal
Description

Reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0947611
Date of decision to withdraw
Description

Date of decision to withdraw

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF patge number if applicable
Description

CRF page number

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Description

Only use this to record explanatory information on anomalies such as missing data, departures from planned investigational product administration or missed visits.

Data type

text

Alias
UMLS CUI [1]
C0947611
Investigator's signature
Description

Investigator's signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
Signature date
Description

Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Liver Events Assessment
C0232741 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0232741 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Liver Events Assessment
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Status of Treatment Blind
C3897431 (UMLS CUI-1)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment Blind Broken
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date blind broken
Item
If yes, date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
If yes, time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken, pick one
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken, pick one
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (Z)
Other Reason blind broken
Item
Other Reason blind broken, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Subject pregnant during study
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (X)
Item
Did a female partner of the male subject become pregnant during the study?
text
C3828490 (UMLS CUI [1,1])
C0919624 (UMLS CUI [1,2])
Subject pregnant during study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (X)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Liver Events Assessment
Code List
Was the subject withdrawn from the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, pick one primary reason for withdrawal:
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary Reason for withdrawal
Code List
If Yes, pick one primary reason for withdrawal:
CL Item
Adverse Event (1)
CL Item
Protocol deviation (3)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Withdrew consent (8)
Reason for withdrawal
Item
Specify reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number
Item
CRF patge number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
Signature Date
Item
Signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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